Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04003233
Other study ID # NL63511.041.17
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date December 1, 2022

Study information

Verified date March 2020
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary aim of this study is to investigate the limited efficacy of these innovative surgical solutions in treatment of Early Onset Scoliosis (EOS) in terms of maintaining reduction while maintaining spinal growth. The secondary aim is to compare both devices for these and other parameters as well as safety.


Description:

Rationale: EOS is a severe and potentially life-threatening disorder since a disturbance of spinal development leads to impaired development of the trunk, with cardio-respiratory failure as a result, often early in adult life. Several innovative solutions have been developed to treat growing children with severe EOS. The SDS device was developed internally at the dpt. of orthopedics at the UMC Utrecht, the Netherlands, the MID-C device was developed by the company ApiFix Ltd.

Objective: The primary aim of this study is to investigate the limited efficacy of these innovative surgical solutions in treatment of early onset scoliosis in terms of maintaining reduction while maintaining spinal growth. The secondary aim is to compare both devices for these and other parameters as well as safety.

Study design: A feasibility study using two prospective cohorts according to an open label randomized clinical trial (RCT) design. The study will be done in two tertiary referral centers (UMC Utrecht and Amsterdam UMC). Primary endpoints are maintenance of curve correction as well as complications. These data will be compared to a recently described cohort of patients that received a "standard treatment" (Magnetically controlled growing rod (MCGR)). The same endpoints as well as secondary outcomes, will be compared between the two new treatments.

Study population: Children with idiopathic(-like) early onset scoliosis with an indication for a growing rod implant.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 1, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria:

- Ambulant skeletally immature children, 6-12 yrs. of age, with open triradiate cartilages on X-ray

- Scoliosis diagnosis prior to the age 10

- Diagnosis of idiopathic or mild syndromic scoliosis (e.g. 22q11DS, Trisomy 21 or 9, Coffin-Siris)

- Progressive scoliosis qualified for growth system surgery

- One curve for treatment with an apex below Th5 and a proximal end vertebra below Th2

- The primary curve must be between 35 and 75 degrees coronal Cobb angle

- The primary curve must be non-rigid (i.e. the curve reduces on bending X-rays to <35 degrees or reduces >30% )

- Normal or hypokyphotic sagittal alignment (Th5 -Th12 < 50 degrees) on lateral X-rays

Exclusion Criteria:

- Patients with an obvious neuromuscular disease

- Patients that are severely mentally retarded

- Patients with a scoliosis that extends to the pelvis or the cervicothoracic region

- Patients with a main curve of more than 8 vertebra Cobb to Cobb

- Patients with a skeletal dysplasia that effects growth (e.g. achondroplasia, SED)

- Patients with a systemic disease which severely influences bone quality (e.g. osteogenesis imperfecta, metabolic diseases)

- Patients with soft tissue weakness (e.g. Ehler Danlos, Marfan, Neurofibromatosis, Prader Willi)

- Patients with an active systemic disease such as Juvenile Idiopathic Arthritis, HIV or oncologic treatment

- Patients with a previous surgical fusion of the spine

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SDS
The SDS will be added to a traditional growing rod (TGR) of 4.5 or 5.5mm.
MID-C
The MID-C system consists of a unilateral one-way ratchet rod that is connected to the spine with polyaxial connectors

Locations

Country Name City State
Netherlands Amsterdam UMC Amsterdam Noord-Holland
Netherlands UMC Utrecht Utrecht

Sponsors (2)

Lead Sponsor Collaborator
UMC Utrecht Apifix

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Limited-efficacy of SDS and MID-C in terms of curve correction maintenance: changes in cobb angle changes in cobb angle on radiographs post-op and at 4 weeks, 3 months and 12 months follow-up (FU). A maximum of 5 degrees increase will be the threshold to define maintenance. Until 1 year post-operative FU
Primary Incidence of Treatment-Emergent Serious Adverse Events of SDS and MID-C Reported treatment related Serious Adverse Events (SAEs) per-operatively and at 4 weeks, 3 months and 12 months FU. Until 1 year post-operative FU
Secondary Limited-efficacy of SDS and MID-C in terms of spinal length Changes in length of T1-T12, T1-S1 and the instrumented segment in mm on calibrated Anterior Posterior (AP) X-rays post-op and at 4 weeks, 3 months and 12 months FU. Until 1 year post-operative FU
Secondary SDS vs. MID-C with respect to limited-efficacy in terms of curve correction maintenance changes in cobb angle on radiographs post-op and at 4 weeks, 3 months and 12 months FU. A maximum of 5 degrees increase will be the threshold to define maintenance. Until 1 year post-operative FU
Secondary SDS vs. MID-C with respect to limited-efficacy in terms of spinal length Changes in length of T1-T12, T1-S1 and the instrumented segment in mm on calibrated AP X-rays post-op and at 4 weeks, 3 months and 12 months FU. Until 1 year post-operative FU
Secondary SDS vs. MID-C with respect to the incidence of Treatment-Emergent Serious Adverse Events Reported treatment related SAEs per-operatively and at 4 weeks, 3 months and 12 months FU. Until 1 year post-operative FU
Secondary SDS vs. MID-C with respect to surgery time Surgery time in minutes Until 1 year post-operative FU
Secondary SDS vs. MID-C with respect to blood loss during surgery blood loss in cc Until 1 year post-operative FU
Secondary SDS vs. MID-C with respect to length of hospital stay length of hospital stay in days Until 1 year post-operative FU
Secondary SDS vs. MID-C with respect to recovery time recovery time in minutes Until 1 year post-operative FU
Secondary SDS vs. MID-C with respect to bone density Bone density changes of the bypassed vertebrae on Dual Energy X-ray Absorptiometry (DEXA)scan post-op and at 3 months en 12 months FU. Until 1 year post-operative FU
Secondary SDS vs. MID-C with respect to Quality Of Life (QOL) on the Early Onset Scoliosis Questionnaires (EOSQ-24) Parent reported QOL and performance is assessed with the 24-item Early Onset Scoliosis Questionnaires (EOSQ-24) pre-op and at 4 weeks, 3 months and 12 months FU. EOSQ-24 covers the following domains: Child's Health Related Quality of Life (16 items), Family Impact (2 items) and Satisfaction (2 items). Until 1 year post-operative FU
Secondary SDS vs. MID-C with respect to flexibility of the spine Flexibility and 3D rotation of the spine on dynamic echography (Scolioscan) Until 1 year post-operative FU
Secondary SDS vs. MID-C with respect to 3D development of the spine Apical Vertebral Rotation based on MRI Until 1 year post-operative FU
Secondary SDS vs. MID-C with respect to patient appearance sagittal balance on clinical photographs post-op and at 1 year FU Until 1 year post-operative FU
See also
  Status Clinical Trial Phase
Completed NCT01795495 - Methadone vs Magnesium in Spinal Fusion Phase 2
Recruiting NCT04539522 - Efficacy of a Three-dimensionally Corrective Exercise Therapy for Scoliosis N/A
Recruiting NCT05128279 - Adolescent and Young Adulte Scoliosis
Withdrawn NCT04633031 - The Effect of Bracing on Sagittal Balance in Scoliosis
Recruiting NCT03978273 - Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients N/A
Recruiting NCT06161038 - Precision Medicine for Nociception, Sngception and Proprioception. N/A
Not yet recruiting NCT06055140 - Evaluation of Thoracolumbar Fascia and Relationship With Low Back Pain in Individuals With Idiopathic Scoliosis
Active, not recruiting NCT05001568 - Validation of a New Optimized Nighttime Providence Brace for Personalized Treatment of Adolescent Idiopathic Scoliosis N/A
Terminated NCT03663088 - Effect of Global Postural Re-education in Idiopathic Scoliosis N/A
Recruiting NCT05575596 - Influence of Social Deprivation and Remoteness on Quality of Life in Adolescent's Surgical Scoliosis
Completed NCT04714632 - Function of Inner Ear Such as Balance and Perception of Verticality in Children With Idiopathic Scoliosis
Not yet recruiting NCT05347056 - The Effect of Vertebral Body Tethering on Lumbar Paraspinal Muscle Cross-Section Area in Adolescent Idiopathic Scoliosis
Completed NCT05333796 - The Effect of Back Muscles Activation on Idiopathic Scoliosis Using Surface Electromyography N/A
Completed NCT03190668 - Skeletal Muscle and Adipose Tissue Study Phase 4
Completed NCT03209752 - Prediction of 3D Effect of Brace in Idiopathic Scoliosis Treatment Using EOS Imaging System and "Anatomic Transfer".
Active, not recruiting NCT02651324 - Efficacy of Ketamine for Improvement in Postoperative Pain Control After Spinal Fusion for Idiopathic Scoliosis Phase 4
Completed NCT01019109 - Scoliosis Surgery Using the PASS® LP System
Not yet recruiting NCT06407843 - Effects of Schroth Method in Idiopathic Scoliosis N/A
Not yet recruiting NCT06298812 - REFLECT Scoliosis System Post Approval Study N/A
Recruiting NCT06331143 - Analgesic Efficacy of Mid-Transverse Process to Pleura (MTP) Block and Intrathecal Morphine in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion N/A